Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial.
Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial.
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DOI：
10.1186/s13063-017-2093-2
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发表时间：
2017-07-24
期刊：
影响因子：
2.5
通讯作者：
Corbett EL
中科院分区：
文献类型：
--
作者：
Choko AT;Fielding K;Stallard N;Maheswaran H;Lepine A;Desmond N;Kumwenda MK;Corbett EL
尽管为诊断艾滋病毒感染者做出了大规模努力，但撒哈拉以南非洲地区仍有 54% 的人未被确诊。对艾滋病毒状况的了解和接受后续服务的差距仍然很大，男性的艾滋病毒检测率远低于女性。在这里，我们设计了一项研究，旨在调查孕妇的男性伴侣中单独进行艾滋病毒自我检测或额外干预对艾滋病毒检测的接受率以及与护理或预防的联系。这是一项 II 期、适应性、多组、多阶段整群随机试验，将产前门诊 (ANC) 天数随机分配到六个不同的试验组。马拉维城市首次接受 ANC 的孕妇将被招募到标准护理 (SOC) 部门（向提供 HIV 检测的男性伴侣发出邀请函）或提供口服 HIV 自检套件的五个干预部门之一。五个干预臂中的三个将另外向男性伴侣提供经济奖励（固定或抽奖金额），条件是在自我测试后与一只臂测试电话提醒进行联动。假设 25% 的男性伴侣参与 SOC 组的护理或预防，则每组 6 个临床日（21 名合格参与者的调和平均值）将提供 80% 的功效来检测主要结果中 0.15 的绝对差异。聚类比例将通过聚类摘要方法进行分析，并对聚类和多重性进行调整。该试验采用了新颖且高效的设计的自适应方法。这里学到的方法和经验教训对于未来如何设计和进行类似研究的概念证明非常重要。尽管规模较小，但这项试验可能会为改善与 ART 或预防的联系的有效干预措施类型提供良好的证据。试验结果还将对如何针对首次使用 ANC 的孕妇的男性伴侣实施 HIVST，同时特别注意安全问题产生重要的政策影响。如果干预组的女性与 SOC 组的女性共用自检套件，则可能会发生污染。 ISRCTN，ID：18421340。注册于 2016 年 3 月 31 日。本文的在线版本 (doi:10.1186/s13063-017-2093-2) 包含补充材料，可供授权用户使用。
Despite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women. A phase II, adaptive, multi-arm, multi-stage cluster randomised trial, randomising antenatal clinic (ANC) days to six different trial arms. Pregnant women accessing ANC in urban Malawi for the first time will be recruited into either the standard of care (SOC) arm (invitation letter to the male partner offering HIV testing) or one of five intervention arms offering oral HIV self-test kits. Three of the five intervention arms will additionally offer the male partner a financial incentive (fixed or lottery amount) conditional on linkage after self-testing with one arm testing phone call reminders. Assuming that 25% of male partners link to care or prevention in the SOC arm, six clinic days, with a harmonic mean of 21 eligible participants, per arm will provide 80% power to detect a 0.15 absolute difference in the primary outcome. Cluster proportions will be analysed by a cluster summaries approach with adjustment for clustering and multiplicity. This trial applies adaptive methods which are novel and efficient designs. The methodology and lessons learned here will be important as proof of concept of how to design and conduct similar studies in the future. Although small, this trial will potentially present good evidence on the type of effective interventions for improving linkage into ART or prevention. The trial results will also have important policy implications on how to implement HIVST targeting male partners of pregnant women who are accessing ANC for the first time while paying particular attention to safety concerns. Contamination may occur if women in the intervention arms share their self-test kits with women in the SOC arm. ISRCTN, ID: 18421340. Registered on 31 March 2016. The online version of this article (doi:10.1186/s13063-017-2093-2) contains supplementary material, which is available to authorized users.
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影响因子：
3.7
作者：
Nyondo, Alinane Linda;Choko, Augustine Talumba;Muula, Adamson Sinjani
通讯作者：
Muula, Adamson Sinjani
影响因子：
2.6
作者：
Chikovore J;Hart G;Kumwenda M;Chipungu GA;Corbett L
通讯作者：
Corbett L
影响因子：
105.7
作者：
Campbell, Marion K.;Piaggio, Gilda;Altman, Douglas G.
通讯作者：
Altman, Douglas G.
制定和评估复杂的干预措施：新的医学研究委员会指南。
DOI：
10.1136/bmj.a1655
发表时间：
2008-09-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Craig P;Dieppe P;Macintyre S;Michie S;Nazareth I;Petticrew M;Medical Research Council Guidance
通讯作者：
Medical Research Council Guidance
影响因子：
1.9
作者：
BAUER, P;KOHNE, K
通讯作者：
KOHNE, K